Evaluation of The Effectiveness of The SAFE Early Intervention Program

NCT ID: NCT06930482

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-01

Brief Summary

In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.

Conditions

Preterm; Sensory Disorders; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SAFE Early Intervention Group

Group Type: EXPERIMENTAL

Safe early intervention

Intervention Type: BEHAVIORAL

The SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary.

early intervention approach based on neurodevelopmental treatment

Intervention Type: BEHAVIORAL

Within the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention).

Control Group

Group Type: OTHER

Safe early intervention

Intervention Type: BEHAVIORAL

The SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary.

early intervention approach based on neurodevelopmental treatment

Intervention Type: BEHAVIORAL

Within the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention).

Interventions

Safe early intervention

The SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary.

Intervention Type: BEHAVIORAL

early intervention approach based on neurodevelopmental treatment

Within the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion Criteria

• Having a genetic syndrome diagnosis (e.g. Down Syndrome)
• Parents do not speak Turkish

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Simsek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erzurum Technical University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yildiz R, Yildiz A, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial. J Paediatr Child Health. 2025 Sep 2. doi: 10.1111/jpc.70191. Online ahead of print.

Reference Type: DERIVED

PMID: 40891629 (View on PubMed)

Other Identifiers

91610558-302.08.01-122723

Identifier Type: -

Identifier Source: org_study_id